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中国生物工程杂志

China Biotechnology
China Biotechnology  2019, Vol. 39 Issue (12): 95-102    DOI: 10.13523/j.cb.20191212
    
The Clinical Use and Insurance of Biosimilars in the US ——Taking the Pfizer vs. Johnson Lawsuit as an Example
DONG Xin-yue,JIANG Rong,LIZHA Adelietibieke,SHAO Rong()
The Research Center of National Drug Policy & Ecosystem, China Pharmaceutical University, Nanjing 211198, China
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Abstract  

In recent years, the global development of biosimilars is in full swing. Governments have introduced a series of incentive policies to promote the development and application of biosimilars, in addition, large-scale pharmacy enterprises have also seized biosimilars’ market opportunities through the acquisition of other small and medium-sized biopharmaceutical companies. The Pfizer vs. Johnson lawsuit was taken as a research object, and the overall description of American biosimilars insurance policies, development process of litigation case and in-depth analysis of series focus issues were carried out. The study found that the competitive pressures from the original companies and the clinical conservative attitudes towards the substitutability of biosimilars threaten the application and promotion of biosimilars to a certain extent, while its price advantage and increasingly clear policy environment make the future of biosimilars promising.



Key wordsUS      Biosimilars      Pfizer vs. Johnson lawsuit      Clinical substitutability      Monopoly     
Received: 13 April 2019      Published: 15 January 2020
ZTFLH:  R951  
Corresponding Authors: Rong SHAO     E-mail: shaorong118@163.com
Cite this article:

DONG Xin-yue,JIANG Rong,LIZHA Adelietibieke,SHAO Rong. The Clinical Use and Insurance of Biosimilars in the US ——Taking the Pfizer vs. Johnson Lawsuit as an Example. China Biotechnology, 2019, 39(12): 95-102.

URL:

https://manu60.magtech.com.cn/biotech/10.13523/j.cb.20191212     OR     https://manu60.magtech.com.cn/biotech/Y2019/V39/I12/95

药品名 上市时间 上市途径 二者关系 定价情况
Remicade/Infliximab 1998.08.24 BLA 103772 创新生物药 7 235美元/年
Inflectra/Infliximab-dyyb 2016.05.04 BLA 125544 生物类似药 6 149美元/年
Table 1 The cost comparison of Remicade and Inflectra to single patient
Fig.1 Global sales of Remicade & Johnson’s sales revenue and growth rate in recent 10 years (million dollars) Data sources: https://www.sohu.com/a/229122197_542695, Johnson's annual report summary
公司名称 具体保障措施
UnitedHealthcare “首试失败”:仅在使用Remicade首次失败后才可使用其生物类似药
Anthem 完全排斥使用生物类似药
Aetna 制定了批准使用生物类似药之前的复杂指示清单
Cigna “首试失败”:仅在使用Remicade首次失败后才可使用其生物类似药
Table 2 Specific implementation form of “exclusive contract”
类别 归属 保障对象 制度归属
Medicare A 医疗福利
计划
医院和设施费用:共用病房、膳食、护理、临终关怀、家庭保健、专业护理设施等 Original Medicare计划,联邦政府管理
Medicare B 医院外诊疗费用:医生问诊、门诊手术、预防性护理(如流感疫苗注射)等
Medicare C 住院和医疗费用:A、B部分的所有内容甚至更多,还包括预防性牙科、眼科诊疗费用 Medicare Advantage计划,私人医保公司管理 Medicare Advantage计划中部分内置了D部分处方药计划的功能[8]
Medicare D 药物福利
计划
处方药费用:大部分常用品牌药和仿制药 处方药计划,私人医保公司管理
Table 3 Specific rules of Medicare system in the US
Fig.2 Market situation of infliximab (reimbursement volume) in 2017.01.01-2017.06.30 Source:Medicare 100% Carrier claims 1Q-2Q 2017, CareSet Systems, Inc.
类别 实施主体 具体规定 意义
Medicare B CMS 制定生物类似药报销编码政策,根据医疗保险通用程序编码系统(HCPCS)对同参照品的所有生物类似药分组,称为J-码 自2018-01-01起,新批准的、具有同参照品的生物类似药将不再使用相同的报销代码,所有生物类似药具有独立J代码,并基于各自的ASP报销
基于同一HCPCS代码中包含的所有生物类似药的ASP进行支付
每个生物类似药的报销额在其ASP基础上加参考品ASP的6%计算
Medicare D CMS 改革前:药品厂商应为覆盖范围内的患者提供50%的折扣(品牌药),生物类似药被排除在此范畴外 可能使类似药比Medicare D中品牌药更昂贵
改革后:要求生物类似药与原研生物药一样向参保人提供50%折扣的保险覆盖差额 对生物类似药持鼓励态度
Medicaid 各州 生物类似药可能被纳入各州医疗补助计划的首选药物清单 生物类似药不需要像非首选药那样去请求事先授权
CMS 生物类似药厂商须在法定所有生物类似药平均厂商价格23.1%折扣(一般仿制药折扣:13.1%)基础上提供额外折扣 刺激生物类似药的使用;降低政府报销支出
Table 4 Special regulations on reimbursement of biosimilars in the system of Medicare B, Medicare D and Medicaid
生产商 强生公司 辉瑞制药公司 其他
药品名称 Remicade Inflectra
类别 创新生物药 生物类似药 百分比
批发采购价 $ 1 173 $ 997 15% 比Remicade低的百分比
排他性折扣 $2 000 000 000
单位数量折扣 $ 400 40% 辉瑞的百分比折扣力度
每年小瓶销售量 6 000 000 275 000 4% Inflectra市场销量占比
有效单位折扣 $ 333 $ 400
有效单位净价 $ 840 $ 597
“单位-单位比较” $ 243
清单外优惠 0 $ 48 386 250
额外折扣 $ 2 000 000 000 $110 000 000 若辉瑞同Remicade销量: $ 2 400 000 000
全部清单外优惠 $ 2 000 000 000 $ 158 386 250 若辉瑞同Remicade销量: $ 2 448 386 250
“折扣-折扣比较” $ 1 841 613 750 若辉瑞同Remicade销量: $ 448 386 250
Table 5 Prices of Infliximab and its biosimilar
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